Latest news with #MPox
Economic Times
2 days ago
- Health
- Economic Times
Health emergency: Deadly Mpox strain Clade 1 hits Australia, only the 2nd case ever
IANS Rare and dangerous mpox strain detected in Queensland A rare and more dangerous strain of the Mpox virus, known as Clade 1, has been confirmed in Queensland, marking the first-ever case in the state and only the second known detection of this strain in Australia's history. Queensland Health officials say the individual had recently returned from overseas and was diagnosed while seeking care at Logan Hospital in the state's Metro South region. Contact tracing is currently underway, and public health teams are working to identify and notify anyone who may have been exposed. 'Clade 1 is notorious for causing a more widespread rash, big blisters or pox-like lesions, typically all over the body,' said Dr. Paul Griffin, infectious diseases expert. 'And because it is more severe, they can have other symptoms like high fevers.'The virus, previously known as monkeypox, spreads primarily through close, prolonged, or intimate contact, including skin-to-skin contact or exposure to bodily fluids, respiratory droplets, or contaminated materials like clothing or bedding. The patient is in isolation, and authorities say there is no current threat to the broader community. Mpox Clade 1 is far more severe than Clade 2, the milder strain that caused most of Australia's 2022 outbreak. Clade 1 has been associated with higher rates of complications, including secondary infections and in rare cases, first Australian case of Clade 1 was reported in New South Wales in May 2025, also in a traveler returning from Africa. Clade 1 is more common in Central Africa and has been spreading more widely in the past year, prompting increased surveillance globally. What is MPox?Mpox is a viral infection similar to smallpox, but typically milder. It causes fever, body aches, swollen lymph nodes, and a characteristic blistering rash. What makes Clade 1 different? Clade 1 is a more dangerous strain. It causes larger, widespread blisters, more severe fever, and sometimes serious complications. It has a higher mortality rate than Clade 2, particularly in countries with limited healthcare access. How does Mpox spread? Mpox spreads through: Close or intimate contact (skin-to-skin, kissing, sex) Contact with lesions or scabs Respiratory droplets in close, prolonged face-to-face interaction Contaminated clothing, bedding, or surfaces Who is at risk?While anyone can contract Mpox, the risk is higher for: People with multiple intimate partners Travelers returning from endemic areas Close contacts of confirmed cases Healthcare and frontline workers Is there a vaccine?Yes. Australia offers free MPox vaccines to high-risk individuals. Two doses are recommended for full protection. Contact your local sexual health clinic or GP to book.
Time of India
2 days ago
- Health
- Time of India
Health emergency: Deadly Mpox strain Clade 1 hits Australia, only the 2nd case ever
A rare and more dangerous strain of the Mpox virus, known as Clade 1, has been confirmed in Queensland, marking the first-ever case in the state and only the second known detection of this strain in Australia's history. Queensland Health officials say the individual had recently returned from overseas and was diagnosed while seeking care at Logan Hospital in the state's Metro South region. Contact tracing is currently underway, and public health teams are working to identify and notify anyone who may have been exposed. Explore courses from Top Institutes in Select a Course Category Data Analytics Leadership Others Design Thinking Cybersecurity healthcare others Product Management MCA Management Digital Marketing Degree MBA Operations Management Data Science Healthcare Artificial Intelligence Finance Public Policy Data Science Project Management CXO Technology PGDM Skills you'll gain: Data Analysis & Visualization Predictive Analytics & Machine Learning Business Intelligence & Data-Driven Decision Making Analytics Strategy & Implementation Duration: 12 Weeks Indian School of Business Applied Business Analytics Starts on Jun 13, 2024 Get Details 'Clade 1 is notorious for causing a more widespread rash, big blisters or pox-like lesions, typically all over the body,' said Dr. Paul Griffin, infectious diseases expert. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Unbelievable: Calculator Shows The Value Of Your House Instantly (Take a Look) Home Value Calculator Search Now Undo 'And because it is more severe, they can have other symptoms like high fevers.' The virus, previously known as monkeypox, spreads primarily through close, prolonged, or intimate contact, including skin-to-skin contact or exposure to bodily fluids, respiratory droplets, or contaminated materials like clothing or bedding. Live Events The patient is in isolation, and authorities say there is no current threat to the broader community. Rare but serious threat Mpox Clade 1 is far more severe than Clade 2, the milder strain that caused most of Australia's 2022 outbreak. Clade 1 has been associated with higher rates of complications, including secondary infections and in rare cases, death. The first Australian case of Clade 1 was reported in New South Wales in May 2025, also in a traveler returning from Africa. Clade 1 is more common in Central Africa and has been spreading more widely in the past year, prompting increased surveillance globally. FAQs What is MPox? Mpox is a viral infection similar to smallpox, but typically milder. It causes fever, body aches, swollen lymph nodes, and a characteristic blistering rash. What makes Clade 1 different? Clade 1 is a more dangerous strain. It causes larger, widespread blisters, more severe fever, and sometimes serious complications. It has a higher mortality rate than Clade 2, particularly in countries with limited healthcare access. How does Mpox spread? Mpox spreads through: Close or intimate contact (skin-to-skin, kissing, sex) Contact with lesions or scabs Respiratory droplets in close, prolonged face-to-face interaction Contaminated clothing, bedding, or surfaces Who is at risk? While anyone can contract Mpox, the risk is higher for: People with multiple intimate partners Travelers returning from endemic areas Close contacts of confirmed cases Healthcare and frontline workers Is there a vaccine? Yes. Australia offers free MPox vaccines to high-risk individuals. Two doses are recommended for full protection. Contact your local sexual health clinic or GP to book.
Miami Herald
6 days ago
- Health
- Miami Herald
WHO Extended Global Emergency Status of MPox Epidemic - Development of Treatment for MPox with NV-387 is Timely, Says NanoViricides
SHELTON, CONNECTICUT / ACCESS Newswire / July 16, 2025 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, comments on the extension of the MPox Public Health Emergency of International Concern (PHEIC) by WHO. The Director General of WHO has extended the PHEIC declaration for MPox epidemic according to a WHO news release dated July 10, 2025, following continuing upsurge of the MPox virus (MPXV) epidemics in the African region[1]. Sporadic travel related cases of MPXV Clade I have occurred outside Africa, including in the USA, but so far have not resulted in further transmission. The threat of such sustained transmission continues, and is part of the decision to continue the PHEIC status. "Our development of NV-387 towards Phase II clinical trial for treatment of MPOX is timely for responding to the continuing threat of a global spread of MPox, and for meeting the need for treatment of MPox patients in Africa, in light of the continuing spread of MPox," said Anil R. Diwan, PhD, President and Executive Chairman of NanoViricides, Inc., adding, "If successful, this NV-387 clinical trial will also open up a multi-billion-dollar global market of preparedness for poxvirus bioterrorism to us." At present, there is no drug approved, that is actually safe and effective in humans, for the treatment of the MPox disease, which is caused by MPXV infection. Tecovirimat (SIGA) has failed to show any effectiveness over standard of care in a clinical trial for treatment of MPXV infections. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study"[2], [3]. In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial[4]. The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results. The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles[5]. The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX. In contrast to the small chemical drugs, vaccines, antibodies, that viruses escape readily, NV-387, the novel broad-spectrum antiviral developed by the Company, is designed such that viruses would not escape the drug. This is because NV-387 mimics the cell-side feature called heparan sulfate proteoglycans (HSPG) to which the viruses bind and concentrate next to the cell before they can attack the cell and cause infection. No matter how much a human pathogenic virus mutates, it continues to bind to HSPG. Over 90% of human pathogenic viruses are known to bind to HSPG. Additionally, NV-387 has been found to be extremely safe and well tolerated in a Phase I human clinical trial. There were no reported adverse events or serious adverse events in this clinical trial. In animal studies, NV-387 was found to be extremely safe, with a No-Observed-Adverse-Event Level (NOAEL) of the drug at 1,200 mg/kg, and the Maximum Tolerated Dose (MTD) at 1,500 mg/kg in intravenous injection in rats. The Phase I clinical trial results for NV-387 were consistent with the safety observations in animal model studies. NV-387 is orally available and is formulated as oral gummies that are soft solids that do not require swallowing, and are designed to dissolve in the oral cavity itself. This is important because MPox patients may not have the ability to swallow pills or capsules because of viral lesions in the oral cavity. The Company recently announced that it has completed the development of a clinical trial protocol for the impending Phase II study of NV-387 for the treatment of MPox disease in the African Region. This will be a randomized clinical trial comparing NV-387 treatment with the Standard of Care, to evaluate the dosing regimen for NV-387, the safety and tolerability of the dosing regimen in MPox patients, and effectiveness of NV-387 on the MPXV virus and the MPox disease that it causes. Of note, both tecovirimat and brincidofovir were approved by the US FDA for smallpox virus, based on the "Animal Rule", which avoids the use of human efficacy clinical trials that would be unethical to conduct with a smallpox challenge study in humans. We also note that smallpox is a more severe disease than even the most severe form of MPox disease, and both of these drugs have been found to be inadequate for the treatment of MPox according to currently available datasets (although definitive data from the brincidofovir clinical trial has not been released yet). These two drugs (tecovirimat and brincidofovir) have been acquired in the US Strategic National Stockpile for bioterrorism preparedness to the tune of around billion dollars. The overall global market for bioterrorism preparedness against smallpox variants is estimated to be several billions of dollars. The Company anticipates that a successful Phase II clinical trial of NV-387 for the treatment of MPox would open up the US Government SNS market and similar global markets to our drug and benefit the Company's other programs as well. MPXV Clade Ib strain is dominant in major parts of Africa and continues to spread, whereas the less virulent MPXV Clade IIb strain is dominant in Sierra Leone, with cases increasing at present. While vaccination has started, overall, the uptake of available vaccines has remained lower than anticipated due to logistical, operational, and financial barriers, according to the report of the International Health Regulations (2005) (IHR) Emergency Committee for MPox of the WHO on June 5, 2025. MPXV Clade II has become epidemic, within limited population demographics, in the Western world including the USA since a 2022 epidemic it caused, driven by travel-related transfer from Western Africa. The PHEIC regarding MPox 2024 was first declared on August 14, 2024, and was extended in February 2025. It has been extended again now as the MPXV continues to spread in neighboring countries in Africa threatening further global spread and sustained transmission. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments. The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development. Contact:NanoViricides, Public Relations Contact:ir@
Miami Herald
14-07-2025
- Business
- Miami Herald
Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides
SHELTON, CT / ACCESS Newswire / July 14, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announces that the design of the adaptive clinical trial protocol for the treatment of MPox Virus Clade Ia and Ib infections and disease is nearly complete. The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial: safe and effective dosing regimen in patients,safety and tolerability of the drug in patients, andantiviral effectiveness of the drug in patients. The overall clinical trial will enroll approximately 80 patients. "This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease." Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease. NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus. If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions. MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits. Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC [1] . The adaptive, randomized, SOC controlled clinical trial will proceed in two parts: In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease. There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results. In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy. The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region. The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash. Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial. Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found. The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about 3%-11% whereas the CFR for Clade 1b is about 1%. The MPox Clade 2b is the virus causing continuing cases in the Western world, which causes a much less severe disease than Clade 1a/1b and has a very low CFR, according to CDC. Sporadic cases of Clade 1 in the Western world continue to occur. Four separate travel-related MPox Clade 1 cases reported in the USA that did not result in any further spread, since November 2024, according to the CDC [3] . Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments. The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development. Contact:NanoViricides, Public Relations Contact:ir@
Associated Press
07-07-2025
- Business
- Associated Press
NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
NanoViricides, Inc. (NYSE Amer.: NNVC), a clinical-stage biopharmaceutical company and a pioneer in broad-spectrum antivirals, announced today its accelerated plans to advance its lead drug candidate, NV-387, into Phase II clinical trials for MPox. This strategic decision positions the company to potentially bring a much-needed antiviral to market faster, addressing a critical global health need while also paving the way for further pipeline development. NanoViricides highlighted several key reasons for prioritizing MPox as the first indication for NV-387's Phase II development, even with strong efficacy data in animal studies for other major viral threats like RSV, Influenza, and COVID. Strategic Advantages of the MPox Focus The company believes its focus on MPox offers significant advantages: Urgent Need and Timely Trial Completion: With a continuing MPox epidemic in the African Region, there's a pressing demand for effective treatments. This also facilitates patient recruitment, enabling a more rapid completion of the clinical trial. Cost-Effectiveness: Conducting clinical trials in the African Region is substantially more economical compared to the US or Europe, allowing NanoViricides to optimize its research budget. Validation of Animal Model Data: A successful Phase II trial for MPox in humans would validate the company's use of lethal challenge animal models. This is a critical point, as NanoViricides' animal studies have consistently shown NV-387 to be significantly superior to existing drugs across all tested infections. Strong Financial and Public Health Case: The recent failure of tecovirimat (Tpoxx) in MPox clinical trials creates a clear void in the US Strategic National Stockpile (SNS) for effective antivirals against orthopoxviruses like MPox and Smallpox. Both tecovirimat and brincidofovir (Tembexa), currently approved for Smallpox under the 'FDA Animal Rule,' have shown limitations. Brincidofovir failed due to liver toxicity, and tecovirimat demonstrated no superiority over standard care. NanoViricides believes NV-387 could become a crucial addition to the SNS, potentially securing substantial initial acquisition contracts. Addressing a Critical Vulnerability: Unlike small chemical drugs that viruses can readily escape through mutations, NanoViricides' host-mimetic nanomedicine technology is designed to make it difficult for viruses to develop resistance. This is particularly important for bioterrorism readiness, as manipulated forms of viruses like Smallpox could be engineered to resist conventional treatments. The company emphasizes the strong case for the US Department of Health and Human Services (HHS) to support NV-387 development for bioterrorism preparedness. Innovative Drug Delivery Adding to its strategic advantages, NV-387 will be administered as 'NV-387 Oral Gummies.' This soft solid formulation is designed to dissolve naturally in the oral cavity, eliminating the need for swallowing pills or capsules. This is a significant benefit for MPox patients who often suffer from painful oral lesions, making swallowing difficult. Addressing the Broader MPox Threat The ongoing MPox epidemic in the Democratic Republic of Congo (DRC) is driven by Clade 1a and the more transmissible Clade 1b subtypes, which have higher case fatality rates than the Clade 2b circulating in the Western world. While sporadic Clade 1 cases have been reported in the USA without further spread, the potential for a larger epidemic cannot be ignored. NanoViricides asserts that readiness with an effective drug against Clade 1 MPox is crucial for national health security. NanoViricides, Inc. is a publicly traded clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company's innovative nanoviricide™ class of drug candidates is based on technology and proprietary know-how from TheraCour Pharma, Inc. Other notable stocks to keep on top of radar include Summit Therapeutics (SMMT), Regulus Therapeutics (RGLS), Vigil Neuroscience (VIGL), Alaunos Therapeutics (TCRT), CervoMed Inc. (CRVO), Niagen Bioscience (NAGE) and Beam Therapeutics (BEAM). Source: Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of BURU or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated fifteen hundred dollars by a 3rd party EDM Media Consulting Group for content distribution services on nnvc or July 6th, 2025. is neither an investment advisor nor a registered broker. 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Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: [email protected] City: Frisco State: Texas Country: United States Website: Press Release Distributed by To view the original version on ABNewswire visit: NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
